Medical device recalls Moderate risk

Medline Industries, LP recalls Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D…

Recall date
February 25, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1849-2026
FDA classification
Class II
Brand / firm
Medline Industries, LP
Sold / distributed
US Nationwide distribution.

Why it was recalled

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A 5) RADIOLOGY SPINE PACK, Model Number: DYNJ80679A 6) DR CHA CUSTOM PACK, Model Number: DYNJ82370A 7) SPINE PACK HC, Model Number: DYNJ84272

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